1. Field of the Invention
The invention pertains to the field of ameliorating the effect of drugs on the human body. More particularly, the invention pertains to a composition and a method for treatment of the side-effects associated with the administration of cancer chemotherapeutic agents, specifically 5-fluorouracil (5-FU).
2. Description of Related Art
Human beings who develop cancer are often treated with chemotherapeutic drugs. Cancer chemotherapeutic drugs, while effective at destroying a cancerous tumor, may also cause damage to normal tissues of the body. The normal tissues of the body most often affected by the side-effects of a cancer chemotherapeutic drug include the lining of the mouth, the lining of the intestine, and the hair. Symptoms associated with the deleterious effects of chemotherapeutic cancer drugs include hair loss, nausea, and vomiting. Occasionally, the side-effects associated with the administration of cancer chemotherapeutic drugs can be debilitating and result in interruptions of the cancer chemotherapeutic drug treatment regimen.
Various attempts have been made to lessen or to eliminate the symptoms associated with the administration of 5-fluorouracil (5-FU). One approach to mitigate the toxicity of 5-FU is to combine a 5-FU precursor drug with other agents such as oral oxonic acid and 5-chloro-2,4-dihydroxypyridine in the case of S-1. These agents have their own toxicities, including gastrointestinal (GI) toxicity (see, for example, Hoff, “The tegafur-based dihydropyrimidine dehydrogenase inhibitory fluoropyrimidines, UFT/leucovorin (ORZWL) and S-1: a review of their clinical development and therapeutic potential”, Investigational New Drugs, Vol. 18, pp. 331-342, 2000). Other drugs, such as steroids, have been administered to patients to alleviate the suffering associated with the side-effects of cancer treatment using chemotherapy. The success associated with the use of these other drugs to alleviate suffering has not been successful, and as a consequence, the “treatment” is to lower the dose of 5-FU.
Another problem associated with these other drugs is that drugs such as steroids and other drugs used to alleviate the side-effects of cancer drugs may be toxic to other tissues. Such tissue toxicity produces additional unwanted side-effects.
A third problem associated with drugs administered to alleviate the side-effects of cancer therapy is that the drug used to alleviate the side-effects caused by the cancer drug may interfere with the activity of the cancer drug, resulting in diminished effectiveness for destroying the targeted cancerous tumor.
Accordingly, there remains a need in the art for a composition and method for the treatment of the side-effects associated with the administration of 5-FU and 5-FU precursor drugs, such as capecitabine.